Chief Regulatory Officer for an Immuno-Oncology Startup

Client background

This early-stage biotech startup is developing intra-tumoral immunotherapies to fight cancer in a new way. With 12 employees and $30 million in seed money, the company plans to file two INDs in 2023 for their fixed-dose combination drug candidates.   


The CMO needed to hire a Chief Regulatory Officer who could oversee all aspects of Regulatory Affairs for their development programs and get their metastatic cancer programs into the clinic. They needed a seasoned Regulatory leader who could build out the Regulatory function and also serve as a member of the company’s Executive Leadership Team. Ideally, they wanted to fill this role by the end of the year.


Dennis Partners conducted a Retained Search to find the best possible candidates for our client. Because they did not have a formal HR department, we kicked off the search in September with the CMO, CEO, and other members of their executive team to understand their needs for this position. We provided the client with advice regarding the level of the role, title, scope and expected salary range. We focused our search on senior Regulatory Affairs leaders who had experience with Immuno-Oncology programs and relationships with the FDA’s Office of Oncologic Diseases.  Within a matter of weeks, we identified, screened, and submitted multiple candidates who met the qualifications for the role.    


The client conducted initial video interviews with the top six candidates, and then advanced the top three to in-person interviews.  Once they selected their top choice, Dennis Partners checked references and negotiated the offer.  The candidate accepted the position and started in late December. Our client and the new Chief Regulatory Officer are both thrilled.